Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax

NCT02508688 | Completed

• 1 other identifier: 201506012RIND
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The study will discuss the perioperative treatment, effectiveness, and morphology of diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors associated with increased three-month mortality in these critically ill patients will be studied.

Conditions

Liver Cirrhosis

Keywords

hepatic hydrothorax; thoracoscopic surgery; diaphragmatic defect

Outcome Measures

Primary Outcomes (2)

• one-month mortality

  one-month mortality after thoracoscopic mesh repair

  one month

• three-month mortality

  three-month mortality after thoracoscopic mesh repair

  three month

Secondary Outcomes (1)

• recurrence of hepatic hydrothorax

  20.5 months

Study Arms (1)

thoracoscopic mesh repair group

EXPERIMENTAL

63 patients with refractory HH (\> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair were included in this study.

Procedure: thoracoscopic diaphragmatic repair

Interventions

thoracoscopic diaphragmatic repair PROCEDURE

patients with refractory hepatic hydrothorax (\> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair

thoracoscopic mesh repair group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with refractory hepatic hydrothorax (\> 3 times thoracentesis and failure to maximal doses of diuretics)

You may not qualify if:

• Patients with systemic bacteremia, positive culture of bacteria of pleural effusion or ascites were excluded from the study because of potential mesh contamination.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Links

• Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom Inventory
• Effect of the amount of intraoperative fluid administration on postoperative pulmonary complications following anatomic lung resections
• Hepatorenal Disorders
• Management of refractory hepatic hydrothorax
• Hepatic hydrothorax
• Percutaneous transhepatic biliary drainage complicated with hepatic hydrothorax
• Color Doppler ultrasonography in detecting transdiaphragmatic flow of hepatic hydrothorax: correlation with thoracoscopic findings
• Thoracoscopic diaphragmatic repair for refractory hepatic hydrothorax: application of pleural flap and mesh onlay reinforcement
• The morphology of diaphragmatic defects in hepatic hydrothorax: thoracoscopic finding

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Ming Huang, MD, PhD

  Department of Surgery, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 27, 2015
• Study Start: January 1, 2005
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07